International Journal of Gynecology and Obstetrics 124 (2014) 198–203
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REVIEW ARTICLE
A review of the contemporary evidence on rescue cervical cerclage Hatem Abu Hashim a,⁎, Hesham Al-Inany b, Zaid Kilani c a b c
Department of Obstetrics and Gynecology, Faculty of Medicine, Mansoura University, Mansoura, Egypt Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt Farah Hospital, Amman, Jordan
a r t i c l e
i n f o
Article history: Received 22 April 2013 Received in revised form 17 August 2013 Accepted 27 November 2013 Keywords: Emergency cervical cerclage Emergent cerclage Perinatal outcome Rescue cerclage
a b s t r a c t Background: Rescue cervical cerclage (RCC) is essentially a salvage procedure to prolong pregnancy in women with advanced cervical changes and prolapsed membranes in the second trimester. However, its effectiveness and safety remain controversial. Objectives: To provide a comprehensive review of the contemporary evidence on RCC and evaluate which treatment modalities can be offered to pregnant women based on the best available evidence. Search strategy: A PubMed search of published studies on RCC and perinatal outcome was conducted using defined keywords. Selection criteria: Clinical studies were included with priority for level I evidence (randomized controlled trials [RCTs]) followed by other evidence levels. Data collection and analysis: Abstracts of 141 articles were screened and 40 articles were selected. Main results: Evidence from retrospective and nonrandomized prospective trials shows a benefit of RCC. It may prolong pregnancy by an average of 4–5 weeks, with a 2-fold reduction in the chance of preterm birth before 34 weeks. A higher chance of failure is expected if cervical dilatation exceeds 4 cm or if membranes are bulging into the vagina. Conclusions: The decision for an RCC should be individualized after comprehensive counseling by a senior obstetrician. Further research in the form of robust RCTs is recommended. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Cervical cerclage is a well-known surgical procedure, commonly used during pregnancy for the management of women considered to be at high risk of second-trimester abortion and spontaneous preterm birth (PTB). The procedure can be categorized as elective (historyindicated) cerclage, urgent (ultrasound-indicated) cerclage, or emergency or emergent (rescue) cerclage [1]. Elective or history-indicated cerclage is inserted as a prophylactic measure in asymptomatic high-risk women, usually at 12–14 weeks of pregnancy. By contrast, an urgent or ultrasound-indicated cerclage is inserted as a therapeutic measure in women with a short cervix and particularly in the presence of funneling of the membranes into the endocervical canal as discovered by transvaginal ultrasound, usually in asymptomatic women before 24 weeks of pregnancy [1,2]. Emergency or rescue cervical cerclage (RCC) is essentially a salvage procedure to prolong gestation in women with advanced cervical changes and prolapsed membranes in the second trimester identified by transvaginal ultrasound, speculum, or manual examination carried
⁎ Corresponding author at: Department of Obstetrics and Gynecology,Faculty of Medicine, Mansoura University, El-Gomhoria St. Mansoura, 35511 Egypt. Tel.: +20 502300002; fax: +20 502234030. E-mail address: [email protected] (H. Abu Hashim).
out in the presence of symptoms such as vaginal bleeding, discharge, or pelvic pressure sensation [1,2]. Importantly, the effectiveness and safety of this procedure remain controversial. The present review was conducted to examine the contemporary evidence on RCC and to evaluate which treatment modalities can be offered to pregnant women based on the best available evidence.
2. Materials and methods A PubMed search was performed with the following search terms: “emergency cervical cerclage” OR “emergent cervical cerclage” OR “rescue cerclage” and “perinatal outcome.” The search included articles published between January 1, 1974, and January 14, 2013, and was not restricted by language or other search limits. In total, 141 articles were retrieved (Fig. 1). The abstracts were screened to identify articles on clinical trials in which RCC was performed for women with cervical dilatation and bulging membranes and fetal outcome was assessed. A study with multiple treatment groups was included if it had an RCC treatment arm; however, only information from that treatment arm was used. Each retrieved manuscript was carefully evaluated, and any relevant references cited in these reports were also obtained and reviewed. Different aspects of RCC including preoperative, operative, and postoperative considerations as well as predictors of success were reviewed separately.
0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.08.021
H. Abu Hashim et al. / International Journal of Gynecology and Obstetrics 124 (2014) 198–203
Records identified (n=141)
Records screened (n=141)
Full-text articles assessed for eligibility (n=66)
Records excluded (n=75)
Full-text articles excluded (review, case reports, and small case series, n=26)
Studies included (n=40) Fig. 1. Flow chart of study selection process.
The original clinical studies were selected for inclusion after a quality assessment based on the hierarchy of evidence. Level I evidence (systematic reviews, meta-analyses, and randomized controlled trials [RCTs]) was included where available. In the absence of RCTs investigating a particular aspect of RCC, analytic data from prospective or retrospective studies were reviewed. Finally, observational data, nonsystematic reviews, and committee opinions were evaluated in the absence of either experimental or analytic data. Case reports were not considered to provide sufficiently robust evidence and were excluded. The final selection included 40 studies (Fig. 1). Articles of clinical importance that were published after 14 January 2013 were also added. 3. Results 3.1. Preoperative issues 3.1.1. What information should be given at counseling for RCC insertion? Rescue cervical cerclage performed in women with advanced cervical dilatation with bulging membranes in the second trimester has been referred to as a heroic procedure because of its poor success rate [1,3]. Therefore, all women undergoing this procedure should be informed that there is a lack of RCTs that can sufficiently demonstrate advantages of RCC over a “wait and see” management approach. On the other hand, expectant management can result in a median delay of birth of 2–4 weeks, and if prolapsed membranes are found at 22–23 weeks of pregnancy, a viable neonate may result [4–6]. In view of this uncertainty, a senior obstetrician should be involved in the decision-making process and the selected management approach should aim to prolong the pregnancy as much as possible while at the same time minimizing the risks for mother and neonate, for example chorioamnionitis [7]. Importantly, all contraindications to RCC should be excluded, namely signs of established PTB, evidence of chorioamnionitis, heavy vaginal bleeding, preterm premature rupture of membranes (PPROM), evidence of fetal compromise, major fetal anomalies, and fetal death [2,3]. 3.1.2. Which investigations are required before RCC insertion? It is good practice to check that a recent anomaly scan has been performed [2]. Measurement of the maternal white blood cell count and C-reactive protein (CRP) level on a routine basis to diagnose subclinical chorioamnionitis before performing an RCC is not recommended [2]. Several authors [8,9] have reported an association between histologic evidence of chorioamnionitis in women with PTB or PPROM and a raised maternal CRP level. However, the poor sensitivity and specificity of CRP levels hinders the clinical usefulness of this
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parameter [8,9]. Therefore, these tests should be carried out according to the overall clinical picture [2]. Owing to a lack of evidence from RCTs, routine amniocentesis to rule out infection is not recommended before inserting an RCC. However, a retrospective study [10] showed that amniocentesis before an RCC may be useful because inflammation markers in the amniotic fluid help to predict adverse pregnancy outcomes. Multivariate regression analysis [11] demonstrated that the performance of amniocentesis prior to cerclage was not an independent contributor to PTB before 28 weeks of pregnancy. Notably, many retrospective and uncontrolled studies [12,13] have demonstrated a prolongation of pregnancy with amnioreduction performed before RCC. However, these studies may be affected by many biases, in particular selection bias, making it difficult to confirm or refute the value of amnioreduction. Additionally, there are no studies supporting the benefit of routine screening for genital tract infection before RCC insertion [2]. 3.2. Operative issues 3.2.1. Timing: When to insert an RCC? An observation period of 12–24 hours before RCC insertion has been reported [14] to ensure that PTB, abruption, and infection are excluded. However, this has the potential to increase the risk of an ascending infection by exposure of the fetal membranes to vaginal bacteria [15,16]. In a French retrospective study [17] that evaluated the outcome of RCC among 32 patients, the observation period before RCC comprised less than 48 hours in 16 patients and more than 48 hours in the remaining 16 patients. Among the 32 women, the perinatal outcome was significantly improved if there was absence of bleeding, an unripe cervix, cervical dilatation of less than 2 cm, absence of protruding membranes, and a more advanced pregnancy duration at the time of the procedure. Delivery occurred at a mean of 33.1 weeks of pregnancy, with an 80% postnatal infant survival rate. Notably, the authors found that an observation period of 48 hours before the procedure did not significantly improve perinatal outcomes (P = 0.1 for the gestational age at birth and P = 0.3 for the infant survival rate) among women without uterine contraction and without maternal blood inflammation (no leukocytosis, no CRP increase) at admission. However, selection bias is a major concern with this study owing to its retrospective nature. Accordingly, before advocating more immediate RCC insertion in clinical practice, the results of the French group [17] need to be replicated in a different setting to confirm their external validity. Ideally, an RCT should be performed. Therefore, we need to be honest with our patients and advise that we do not know the best timing for RCC insertion. 3.2.2. Technique If the decision is made to attempt an RCC placement, the prolapsed membranes must be replaced in the uterine cavity before the procedure to avoid the high risk of iatrogenic PPROM. This is accomplished least traumatically by placing the patient in the lithotomy position with a steep Trendelenburg tilt, combined with the administration of tocolytics, and allowing gravity to retract the membranes. Bladder overfilling through a urinary catheter can also help to reposition the membranes in the uterus. However, a full bladder tends to reduce exposure of the operative field and push the cervix higher up into the pelvis [18]. Another option is to place a ring forceps or stay sutures of 00 silk or polyglycolic acid around the circumference of the external os, followed by gently pulling and shaking the cervix or traction on all stay sutures gathered in a parachute fashion to help ease the membranes back into the uterus [19,20]. Invasive methods for reducing the fetal membranes include directly pushing them back with a smooth-surfaced device, such as a Foley catheter balloon (a 25-mL inflated bulb of a size-22 Foley catheter can be used to hold the membranes in the uterus while the cerclage is placed; it is deflated and removed just before the knot is secured) [21], an
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Table 1 Retrospective studies addressing outcomes of RCC insertion. Study design
Number of RCC cases
Number of control patients
Outcome
Stupin et al. 2008 [7]
Retrospective case–control study
89
72 (conservative management, i.e. bed rest, tocolysis, and antibiotics)
Deb et al. 2012 [14]
Retrospective study
20
0
Yip et al. 1998 [15]
Retrospective study
19
0
Abo-Yaqoub et al. 2012 [16]
Retrospective study
43
0
Delabaere et al. 2011 [17]
Retrospective study
32
0
Ventolini et al. 2009 [24]
Retrospective case–control study
56
12 (expectant management)
Güdücü et al. 2013 [28]
Retrospective cohort study
25
0
Terkildsen et al. 2003 [29]
Retrospective with univariable and multivariable analysis
116
0
Debby et al. 2007 [30]
Retrospective cohort study
99 (24 with bulging of membranes and 75 without bulging of membranes)
0
Pereira et al. 2007 [31]
Historical cohort study
152
73 (expectant management)
Gupta et al. 2010 [32]
Retrospective cohort study
45 including 11 twin pregnancies
0
Fortner et al. 2012 [33]
110 (51 with cervical dilatation ≥2 cm and 59 with cervical dilatation b2 cm)
0
Celen et al. 2011 [34]
Retrospective cohort study with multivariate linear regression analysis Retrospective cohort study
75
0
Tezcan et al. 2012 [35]
Retrospective case–control study
Group 1: 19 (bulging membranes and symptoms [pain, pelvic pressure, vaginal discharge]) Group 2: 13 (bulging membranes without symptoms)
23 asymptomatic ultrasound-indicated cerclage
Significant increases in live birth rate (72% versus 25%), median birth weight (1340 g versus 750 g), and pregnancy duration (41 days versus 3 days) in the RCC group Presence of prolapsed membranes with infection causing rupture of membranes was the strongest predictor of poor outcome The duration of cerclage in situ was significantly longer if the procedure was performed at ≤20 weeks or if there were no prolapsed membranes at the time of presentation Significant increases in pregnancy duration at time of delivery and neonatal birth weight in women with RCC after 20 weeks Presence of infection, symptoms (abdominal pain, vaginal bleeding), bulging of membranes through the cervix, and cervical dilatation N3 cm were frequently associated with failure An observation period of 48 hours before the procedure did not significantly improve perinatal outcome if there was no uterine contraction and no maternal blood inflammation at admission Significantly longer median time from diagnosis to delivery in the RCC group (9.1 weeks vs 3.3 weeks) Patients with membranes prolapsing into the vagina had a lower success rate than those with membranes prolapsing to the external os (take-home infant rates of 31.3% and 68.8%, respectively) Nulliparity, membranes prolapsing beyond the external cervical os, and pregnancy duration b22 weeks at RCC were associated with a decreased chance of delivery ≥28 weeks Significantly higher mean pregnancy duration at delivery in the group without bulging of membranes (34.6 ± 4.6 vs 29.5 ± 3.2 weeks, respectively) RCC seems to prolong pregnancy and improve neonatal survival, compared with expectant management Prolapsed membranes, advanced cervical dilatation, maternal symptoms (abdominal discomfort, bleeding), and equivocal markers of infection were associated with a poor outcome Delivery at a shorter pregnancy duration if cervical dilation was ≥2 cm at the time of RCC insertion (27.0 weeks vs 35.6 weeks, P b 0.001) RCC can effectively prolong pregnancy to viability The rate of delivery at N34 weeks was 77.7%; the rate of premature delivery (28–34 weeks) was 12%; the rate of immature delivery (b28 weeks) was 8% RCC and ultrasound-indicated cerclage are best performed prior to symptoms In women with RCC, delivery b32 weeks was significantly more common in group 1 than in group 2 (79% versus 31%, P b 0.05)
Abbreviation: RCC, rescue cervical cerclage.
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Author and year of publication
H. Abu Hashim et al. / International Journal of Gynecology and Obstetrics 124 (2014) 198–203
inflated balloon of the type used for endoscopic preperitoneal dissection [22], or a metreurynter or mini metreu (a rubber balloon device) inside the cervical os [23]. However, such techniques may be associated with an increased risk of iatrogenic PPROM. Alternatively, transabdominal amniocentesis and amnioreduction under ultrasound guidance can be performed to reduce the volume and pressure of the amniotic fluid in the prolapsed sac, thereby allowing the fetal membranes to retract back into the uterine cavity [12]. Emergency McDonald cerclage with the application of stay sutures made of 00 silk or polyglycolic acid has been strongly advocated as being technically easier to perform in an emergency situation with a dilated and effaced cervix, with the stay sutures allowing even traction on the whole cervical circumference, thus providing better conditions for the application of the purse-string suture than traction at 1 or 2 places by surgical instruments [20]. However, the choice between the Shirodkar and McDonald techniques should be made according to surgeon expertise and preference [24]. The application of transverse sutures from the anterior to the posterior parts of the cervix (Wurm technique), alone or in combination with a purse-string suture, has been described [19]. However, there is no current evidence to support the insertion of this cervical occlusion suture or the placement of a double purse-string suture as opposed to a single suture [2]. 3.2.3. Perioperative drugs (tocolytics, prophylactic antibiotics, and anesthesia) Data from uncontrolled retrospective studies [1,14,16,25] support the use of short-term tocolytics (especially indomethacin for its antiinflammatory and tocolytic effects) for 48 hours and the prophylactic administration of broad-spectrum antibiotics for a few days. However, these studies may be affected by biases, in particular selection bias, making it difficult to recommend or refute the value of these treatments. A single course of corticosteroids is recommended in women with a pregnancy duration of 24 weeks or more to enhance fetal lung maturation [26]. No studies are available comparing general with regional anesthesia for cerclage insertion and the decision should be individualized [2]. 3.3. Postoperative care Elective (history-indicated) cerclage is typically a day surgery, so women may be discharged after recovery from anesthesia once they are able to ambulate and void. However, after RCC placement it is good practice for the patient to remain in the hospital for a postoperative observation period of at least 24 hours, because of the increased risk of complications such as PPROM, early PTB, abortion, and infection [2]. On discharge, instructions are usually given to limit physical activity, avoid intercourse, and attend a prenatal clinic for assessment at 2-week intervals, despite the absence of comparative studies addressing these important issues [2,14]. Some authors [14] routinely prescribe supplemental progesterone as empiric medical therapy, but it is noteworthy that there is no evidence to confirm that this is helpful in women with prolapsed membranes. In addition, there are no studies assessing the usefulness of fetal fibronectin testing for the prediction of spontaneous PTB following RCC insertion, despite its high negative predictive value (more than 98%) in women with history- or ultrasound-indicated cerclage [27]. Notably, there are no studies comparing elective cerclage removal with removal during labor. In the absence of established PTB, elective removal at 36–37 weeks of pregnancy is preferable given the risk of cervical trauma should spontaneous labor occur with the suture in place, unless an elective cesarean delivery is to be performed with suture removal during the same setting [2]. In women with PPROM between 24–34 weeks of pregnancy and no infection or PTB, it is advisable to delay suture removal for 48 hours. This allows completion of a prophylactic course of steroids for fetal lung maturation and/or arrangement of an in-utero transfer. However, it is not recommended to delay suture
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removal until the onset of labor, to avoid the risk of maternal and fetal sepsis. Importantly, delayed suture removal is not beneficial in women with PPROM before 23 and after 34 weeks of pregnancy [2]. 3.4. Predictors of success The insertion of an RCC in women with advanced cervical dilatation with bulging membranes in the second trimester is essentially a salvage procedure. No informative RCT with a large sample size has been conducted to identify factors associated with the outcome of RCC. Many retrospective studies [7,14–17,24,28–35] have reported promising findings, with a trend toward improved outcomes with RCC (Table 1). To date, only 1 RCT [4] is available in this context; this trial evaluated the outcomes of RCC over a 5-year period. Twenty-three women who had prolapsed membranes at or beyond the external os before 27 weeks of pregnancy and without clinical signs of infection were randomized. Women in the study group (n = 13; 10 singleton pregnancies, 3 twin pregnancies) received an RCC, perioperative indomethacin, and bed rest until 30 weeks of pregnancy, whereas women in the control group (n = 10; 6 singleton pregnancies, 4 singleton pregnancies) received only bed rest until 30 weeks of pregnancy. A 1-week course of broad-spectrum antibiotics was prescribed for both groups. The 2 groups were demographically similar with a mean pregnancy duration of 22–23 weeks. The study [4] reported a 4-week difference in the pregnancy duration at delivery (mean 29.9 weeks; 95% confidence interval [CI], 24.8–34.9 versus 25.9 weeks; 95% CI, 23.0–29.2) in favor of the cerclage group, with the mean cerclage–delivery interval being 54 days versus 20 days (P = 0.04), and there was a significant reduction in the rate of PTB before 34 weeks of pregnancy (53% versus 100%; P = 0.02). A significant reduction in the rate of neonatal admission to the intensive care unit and/or neonatal death was reported in favor of the cerclage group (71% versus 100%; relative risk [RR], 1.6 [95% CI, 1.1–2.3]), and there was a trend toward an improvement in neonatal survival in the RCC group (56% versus 28%). There are some concerns about this study [4]. First, the study is underpowered (inclusion of only 23 patients, inclusion of twin gestations) to allow a firm conclusion. Second, the RCC group received indomethacin, which might have influenced the results. Third, no data were given on the degree of cervical dilatation and on the incidences of chorioamnionitis and neonatal morbidity. Another prospective nonrandomized study [36] conducted over a 6year period evaluated RCC for asymptomatic low-risk women (mean duration of pregnancy 22–23 weeks) with a dilated cervix (mean 4 cm) and bulging membranes. Women with a history of secondtrimester abortion or spontaneous PTB and those with clinical signs of infection were excluded. In total, 29 women underwent RCC and 17 women were managed expectantly. Pregnancy in the RCC group was prolonged by 8.8 weeks (range 0–17 weeks) compared with 3.1 weeks (range 0–11 weeks) among women who received bed rest alone, with a subsequent 3-fold reduction in PTB before 32 weeks of pregnancy (31% versus 94%; RR 0.33 [95% CI, 0.19–0.57]), a 2-fold increase in the live birth rate (86% versus 41%), and a 40% improvement in neonatal survival (96% versus 57%; RR 0.59 [95% CI, 0.0–0.76]) [36]. The results of this trial seem promising, but it was not randomized. Therefore, selection bias might have influenced the results. Additionally, the study included a small number of patients (n = 46). The use of RCC in twin and multiple pregnancies is a big source of debate. The available evidence from retrospective studies [37,38] indicates that it might be beneficial. One study [37] reported a success rate of 64.4% in terms of delivery beyond 28 weeks, whereas another study [38] reported an incidence of PTB before 34 weeks of 50% (95% CI, 23–77%) and a perinatal survival rate of 86% (95% CI, 67–96%). Properly designed RCTs comparing the outcomes of RCC with the outcomes of bed rest in twin pregnancies are needed to clarify this issue. Interestingly, 2 retrospective studies [25,39] have been carried out to develop a predictive model and a score to estimate the pregnancy
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3) ≥28 weeks of pregnancy (Model C)
Abbreviations: CRP, C-reactive protein; N, nulliparous; P, prior preterm delivery; F, prior full-term delivery; PTB, preterm birth; RCC, rescue cervical cerclage; WBC, white blood cell count. a The total score ranges from 0 to 15 points.
116 A retrospective analysis to develop a predictive model for pregnancy duration at delivery following RCC Grobman et al. 2008 [39]
2) 24–27 weeks of pregnancy (Model B)
0 2 Pregnancy duration at RCC ≤22.1 weeks of pregnancy: n = 74 N22.1 weeks of pregnancy: n = 42 ≤22.8 weeks of pregnancy: n = 95 N22.8 weeks of pregnancy: n = 21 ≤22.1 weeks of pregnancy: n = 74 N22.1 weeks of pregnancy: n = 42
0 4
0 1 2 4
0 4 5
85 A retrospective study with multivariate logistic regression analysis to develop a simple score for assessing the risk of early PTB (before 32 weeks of pregnancy) after RCC insertion
Variable 1) Obstetric history Multigravida without history of PTB Primigravida Multigravida with history of PTB 2) Cervical dilatation 1 cm 2 cm 3 cm ≥4 cm 3) Membranes Visible at external os Bulging into the vagina 4) Infection (WBC ≥13 600/mm3 or CRP N15 mg/L) No Yes Timing of delivery 1) b24 weeks of pregnancy (Model A)
Number of RCC cases Study design/aim
Fuchs et al. 2012 [25]
Author and year of publication
Table 2 Proposed scoring system and predictive model for assessing the risk of PTB in women undergoing RCC.
Main findings
Scorea
Parity N, P: n = 59 F: n = 57 N: n = 38 P, F: n = 78 N: n = 38 P, F: n = 78
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duration at delivery (Table 2), which might be used for prospective decision-making about the need for RCC. Grobman et al. [39] demonstrated that delivery before 24 weeks of pregnancy is best predicted by the presence of prolapsed membranes and the pregnancy duration at RCC insertion, whereas delivery between 24 and 27 weeks of pregnancy is best predicted by parity alone (Table 2). Delivery at a pregnancy duration of 28 weeks or more was best predicted by cervical dilation and length, the presence of prolapsed membranes, and parity. Overall, it was concluded that the last model (cervical dilation and length, presence of prolapsed membranes, and parity) presented the most accurate results to predict delivery at the 3 different pregnancy durations [39]. Fuchs et al. [25] analyzed the outcome of RCC in 85 women with a singleton pregnancy who presented with a spontaneously dilated cervix (dilation 1 cm or more) on physical examination and visible membranes at the external cervical os (n = 37) or with bulging of the membranes into the vagina (n = 48) during speculum examination, and who had no contractions. Multiple logistic regression analysis showed that 4 variables—obstetric history, bulging of membranes into the vagina, cervical dilatation, and infection—independently predicted the risk of early PTB (before 32 weeks) (Table 2). A score ranging from 0 to 15 points was proposed, and total score values of 0, 5, 10, and 15 were associated with early PTB probabilities of 8.6%, 39%, 81.2%, and 97%, respectively [25]. The same authors [40] reported that ultrasound measurement of the cervical length is not better at predicting early PTB (before 32 weeks) than clinical assessment of cervical dilation in women with an RCC. 4. Conclusion A common belief is that RCC may be the only hope to rescue a pregnancy in patients with advanced cervical changes and prolapsed membranes in the second trimester. However, RCC is a surgical procedure with well-defined operative risks. Current evidence from numerous retrospective and a few prospective nonrandomized studies has shown a benefit of RCC. It may prolong pregnancy by an average of 4–5 weeks with a 2-fold reduction in the chance of PTB before 34 weeks of pregnancy. However, data supporting an associated improvement in neonatal mortality or morbidity are limited. Notably, a higher chance of cerclage failure is expected if cervical dilatation exceeds 4 cm or if the fetal membranes are bulging into the vagina. Therefore, the decision to insert an RCC should be individualized and undertaken after comprehensive patient counseling and a review of the specific circumstances, with full involvement of a senior obstetrician. Further research in the form of robust RCTs is recommended to clarify the fundamental concerns in this complex subject area. Conflict of interest The authors have no conflicts of interest. References [1] Nelson L, Dola T, Tran T, Carter M, Luu H, Dola C. Pregnancy outcomes following placement of elective, urgent and emergent cerclage. J Matern Fetal Neonatal Med 2009;22(3):269–73. [2] Royal College of Obstetricians and Gynaecologists. Cervical Cerclage: Green-top Guideline No. 60. http://www.rcog.org.uk/files/rcog-corp/GTG60cervicalcerclage. pdf . Published May 2011. [3] Liddiard A, Bhattacharya S, Crichton L. Elective and emergency cervical cerclage and immediate pregnancy outcomes: a retrospective observational study. JRSM Short Rep 2011;2(11):91. [4] Althuisius SM, Dekker GA, Hummel P, van Geijn HP. Cervical incompetence prevention randomized cerclage trial. Cervical incompetence prevention randomized cerclage trial: emergency cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol 2003;189(4):907–10. [5] Olatunbosun OA, al-Nuaim L, Turnell RW. Emergency cerclage compared with bed rest for advanced cervical dilatation in pregnancy. Int Surg 1995;80(2):170–4.
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[23] Kanai M, Ashida T, Ohira S, Osada R, Konishi I. A new technique using a rubber balloon in emergency second trimester cerclage for fetal membrane prolapse. J Obstet Gynaecol Res 2008;34(6):935–40. [24] Ventolini G, Genrich TJ, Roth J, Neiger R. Pregnancy outcome after placement of 'rescue' Shirodkar cerclage. J Perinatol 2009;29(4):276–9. [25] Fuchs F, Senat MV, Fernandez H, Gervaise A, Frydman R, Bouyer J. Predictive score for early preterm birth in decisions about emergency cervical cerclage in singleton pregnancies. Acta Obstet Gynecol Scand 2012;91(6):744–9. [26] ACOG Committee on Obstetric Practice. ACOG Committee Opinion No. 475: Antenatal corticosteroid therapy for fetal maturation. Obstet Gynecol 2011;117(2 Pt 1):422–4. [27] Duhig KE, Chandiramani M, Seed PT, Briley AL, Kenyon AP, Shennan AH. Fetal fibronectin as a predictor of spontaneous preterm labour in asymptomatic women with a cervical cerclage. BJOG 2009;116(6):799–803. [28] Güdücü N, Işçi H, Aydinli K. Results of midtrimester emergency cerclage. J Reprod Med 2013;58(3–4):143–8. [29] Terkildsen MF, Parilla BV, Kumar P, Grobman WA. Factors associated with success of emergent second-trimester cerclage. Obstet Gynecol 2003;101(3):565–9. [30] Debby A, Sadan O, Glezerman M, Golan A. Favorable outcome following emergency second trimester cerclage. Int J Gynecol Obstet 2007;96(1):16–9. [31] Pereira L, Cotter A, Gómez R, Berghella V, Prasertcharoensuk W, Rasanen J, et al. Expectant management compared with physical examination-indicated cerclage (EMPEC) in selected women with a dilated cervix at 14(0/7)-25(6/7) weeks: results from the EM-PEC international cohort study. Am J Obstet Gynecol 2007;197(5):483.e1–8. [32] Gupta M, Emary K, Impey L. Emergency cervical cerclage: predictors of success. J Matern Fetal Neonatal Med 2010;23(7):670–4. [33] Fortner KB, Fitzpatrick CB, Grotegut CA, Swamy GK, Murtha AP, Heine RP, et al. Cervical dilation as a predictor of pregnancy outcome following emergency cerclage. J Matern Fetal Neonatal Med 2012;25(10):1884–8. [34] Celen S, Simsek Y, Ozyer S, Sucak A, Kaymak O, Turkcapar F, et al. Effectiveness of emergency cervical cerclage in patients with cervical dilation in the second trimester. Clin Exp Obstet Gynecol 2011;38(2):131–3. [35] Tezcan B, Hezelgrave N, Shennan A. The role of cervical ultrasound screening in determining the timing of emergency cerclage. J Obstet Gynaecol 2012;32(5):444–6. [36] Daskalakis G, Papantoniou N, Mesogitis S, Antsaklis A. Management of cervical insufficiency and bulging fetal membranes. Obstet Gynecol 2006;107(2 Pt 1):221–6. [37] Levin I, Salzer L, Maslovitz S, Avni A, Lessing JB, Groutz A, et al. Outcomes of mid-trimester emergency cerclage in twin pregnancies. Fetal Diagn Ther 2012;32(4):246–50. [38] Zanardini C, Pagani G, Fichera A, Prefumo F, Frusca T. Cervical cerclage in twin pregnancies. Arch Gynecol Obstet 2013;288(2):267–71. [39] Grobman WA, Terkildsen MF, Soltysik RC, Yarnold PR. Predicting outcome after emergent cerclage using classification tree analysis. Am J Perinatol 2008;25(7):443–8. [40] Fuchs F, Bouyer J, Fernandez H, Gervaise A, Frydman R, Senat MV. Ultrasound cervical length measurement for prediction of delivery before 32 weeks in women with emergency cerclage for cervical insufficiency. Int J Gynecol Obstet 2010;110(3):245–8.
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International Journal of Gynecology and Obstetrics journal homepage: www.elsevier.com/locate/ijgo
REVIEW ARTICLE
A review of the contemporary evidence on rescue cervical cerclage Hatem Abu Hashim a,⁎, Hesham Al-Inany b, Zaid Kilani c a b c
Department of Obstetrics and Gynecology, Faculty of Medicine, Mansoura University, Mansoura, Egypt Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt Farah Hospital, Amman, Jordan
a r t i c l e
i n f o
Article history: Received 22 April 2013 Received in revised form 17 August 2013 Accepted 27 November 2013 Keywords: Emergency cervical cerclage Emergent cerclage Perinatal outcome Rescue cerclage
a b s t r a c t Background: Rescue cervical cerclage (RCC) is essentially a salvage procedure to prolong pregnancy in women with advanced cervical changes and prolapsed membranes in the second trimester. However, its effectiveness and safety remain controversial. Objectives: To provide a comprehensive review of the contemporary evidence on RCC and evaluate which treatment modalities can be offered to pregnant women based on the best available evidence. Search strategy: A PubMed search of published studies on RCC and perinatal outcome was conducted using defined keywords. Selection criteria: Clinical studies were included with priority for level I evidence (randomized controlled trials [RCTs]) followed by other evidence levels. Data collection and analysis: Abstracts of 141 articles were screened and 40 articles were selected. Main results: Evidence from retrospective and nonrandomized prospective trials shows a benefit of RCC. It may prolong pregnancy by an average of 4–5 weeks, with a 2-fold reduction in the chance of preterm birth before 34 weeks. A higher chance of failure is expected if cervical dilatation exceeds 4 cm or if membranes are bulging into the vagina. Conclusions: The decision for an RCC should be individualized after comprehensive counseling by a senior obstetrician. Further research in the form of robust RCTs is recommended. © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
1. Introduction Cervical cerclage is a well-known surgical procedure, commonly used during pregnancy for the management of women considered to be at high risk of second-trimester abortion and spontaneous preterm birth (PTB). The procedure can be categorized as elective (historyindicated) cerclage, urgent (ultrasound-indicated) cerclage, or emergency or emergent (rescue) cerclage [1]. Elective or history-indicated cerclage is inserted as a prophylactic measure in asymptomatic high-risk women, usually at 12–14 weeks of pregnancy. By contrast, an urgent or ultrasound-indicated cerclage is inserted as a therapeutic measure in women with a short cervix and particularly in the presence of funneling of the membranes into the endocervical canal as discovered by transvaginal ultrasound, usually in asymptomatic women before 24 weeks of pregnancy [1,2]. Emergency or rescue cervical cerclage (RCC) is essentially a salvage procedure to prolong gestation in women with advanced cervical changes and prolapsed membranes in the second trimester identified by transvaginal ultrasound, speculum, or manual examination carried
⁎ Corresponding author at: Department of Obstetrics and Gynecology,Faculty of Medicine, Mansoura University, El-Gomhoria St. Mansoura, 35511 Egypt. Tel.: +20 502300002; fax: +20 502234030. E-mail address: [email protected] (H. Abu Hashim).
out in the presence of symptoms such as vaginal bleeding, discharge, or pelvic pressure sensation [1,2]. Importantly, the effectiveness and safety of this procedure remain controversial. The present review was conducted to examine the contemporary evidence on RCC and to evaluate which treatment modalities can be offered to pregnant women based on the best available evidence.
2. Materials and methods A PubMed search was performed with the following search terms: “emergency cervical cerclage” OR “emergent cervical cerclage” OR “rescue cerclage” and “perinatal outcome.” The search included articles published between January 1, 1974, and January 14, 2013, and was not restricted by language or other search limits. In total, 141 articles were retrieved (Fig. 1). The abstracts were screened to identify articles on clinical trials in which RCC was performed for women with cervical dilatation and bulging membranes and fetal outcome was assessed. A study with multiple treatment groups was included if it had an RCC treatment arm; however, only information from that treatment arm was used. Each retrieved manuscript was carefully evaluated, and any relevant references cited in these reports were also obtained and reviewed. Different aspects of RCC including preoperative, operative, and postoperative considerations as well as predictors of success were reviewed separately.
0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijgo.2013.08.021
H. Abu Hashim et al. / International Journal of Gynecology and Obstetrics 124 (2014) 198–203
Records identified (n=141)
Records screened (n=141)
Full-text articles assessed for eligibility (n=66)
Records excluded (n=75)
Full-text articles excluded (review, case reports, and small case series, n=26)
Studies included (n=40) Fig. 1. Flow chart of study selection process.
The original clinical studies were selected for inclusion after a quality assessment based on the hierarchy of evidence. Level I evidence (systematic reviews, meta-analyses, and randomized controlled trials [RCTs]) was included where available. In the absence of RCTs investigating a particular aspect of RCC, analytic data from prospective or retrospective studies were reviewed. Finally, observational data, nonsystematic reviews, and committee opinions were evaluated in the absence of either experimental or analytic data. Case reports were not considered to provide sufficiently robust evidence and were excluded. The final selection included 40 studies (Fig. 1). Articles of clinical importance that were published after 14 January 2013 were also added. 3. Results 3.1. Preoperative issues 3.1.1. What information should be given at counseling for RCC insertion? Rescue cervical cerclage performed in women with advanced cervical dilatation with bulging membranes in the second trimester has been referred to as a heroic procedure because of its poor success rate [1,3]. Therefore, all women undergoing this procedure should be informed that there is a lack of RCTs that can sufficiently demonstrate advantages of RCC over a “wait and see” management approach. On the other hand, expectant management can result in a median delay of birth of 2–4 weeks, and if prolapsed membranes are found at 22–23 weeks of pregnancy, a viable neonate may result [4–6]. In view of this uncertainty, a senior obstetrician should be involved in the decision-making process and the selected management approach should aim to prolong the pregnancy as much as possible while at the same time minimizing the risks for mother and neonate, for example chorioamnionitis [7]. Importantly, all contraindications to RCC should be excluded, namely signs of established PTB, evidence of chorioamnionitis, heavy vaginal bleeding, preterm premature rupture of membranes (PPROM), evidence of fetal compromise, major fetal anomalies, and fetal death [2,3]. 3.1.2. Which investigations are required before RCC insertion? It is good practice to check that a recent anomaly scan has been performed [2]. Measurement of the maternal white blood cell count and C-reactive protein (CRP) level on a routine basis to diagnose subclinical chorioamnionitis before performing an RCC is not recommended [2]. Several authors [8,9] have reported an association between histologic evidence of chorioamnionitis in women with PTB or PPROM and a raised maternal CRP level. However, the poor sensitivity and specificity of CRP levels hinders the clinical usefulness of this
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parameter [8,9]. Therefore, these tests should be carried out according to the overall clinical picture [2]. Owing to a lack of evidence from RCTs, routine amniocentesis to rule out infection is not recommended before inserting an RCC. However, a retrospective study [10] showed that amniocentesis before an RCC may be useful because inflammation markers in the amniotic fluid help to predict adverse pregnancy outcomes. Multivariate regression analysis [11] demonstrated that the performance of amniocentesis prior to cerclage was not an independent contributor to PTB before 28 weeks of pregnancy. Notably, many retrospective and uncontrolled studies [12,13] have demonstrated a prolongation of pregnancy with amnioreduction performed before RCC. However, these studies may be affected by many biases, in particular selection bias, making it difficult to confirm or refute the value of amnioreduction. Additionally, there are no studies supporting the benefit of routine screening for genital tract infection before RCC insertion [2]. 3.2. Operative issues 3.2.1. Timing: When to insert an RCC? An observation period of 12–24 hours before RCC insertion has been reported [14] to ensure that PTB, abruption, and infection are excluded. However, this has the potential to increase the risk of an ascending infection by exposure of the fetal membranes to vaginal bacteria [15,16]. In a French retrospective study [17] that evaluated the outcome of RCC among 32 patients, the observation period before RCC comprised less than 48 hours in 16 patients and more than 48 hours in the remaining 16 patients. Among the 32 women, the perinatal outcome was significantly improved if there was absence of bleeding, an unripe cervix, cervical dilatation of less than 2 cm, absence of protruding membranes, and a more advanced pregnancy duration at the time of the procedure. Delivery occurred at a mean of 33.1 weeks of pregnancy, with an 80% postnatal infant survival rate. Notably, the authors found that an observation period of 48 hours before the procedure did not significantly improve perinatal outcomes (P = 0.1 for the gestational age at birth and P = 0.3 for the infant survival rate) among women without uterine contraction and without maternal blood inflammation (no leukocytosis, no CRP increase) at admission. However, selection bias is a major concern with this study owing to its retrospective nature. Accordingly, before advocating more immediate RCC insertion in clinical practice, the results of the French group [17] need to be replicated in a different setting to confirm their external validity. Ideally, an RCT should be performed. Therefore, we need to be honest with our patients and advise that we do not know the best timing for RCC insertion. 3.2.2. Technique If the decision is made to attempt an RCC placement, the prolapsed membranes must be replaced in the uterine cavity before the procedure to avoid the high risk of iatrogenic PPROM. This is accomplished least traumatically by placing the patient in the lithotomy position with a steep Trendelenburg tilt, combined with the administration of tocolytics, and allowing gravity to retract the membranes. Bladder overfilling through a urinary catheter can also help to reposition the membranes in the uterus. However, a full bladder tends to reduce exposure of the operative field and push the cervix higher up into the pelvis [18]. Another option is to place a ring forceps or stay sutures of 00 silk or polyglycolic acid around the circumference of the external os, followed by gently pulling and shaking the cervix or traction on all stay sutures gathered in a parachute fashion to help ease the membranes back into the uterus [19,20]. Invasive methods for reducing the fetal membranes include directly pushing them back with a smooth-surfaced device, such as a Foley catheter balloon (a 25-mL inflated bulb of a size-22 Foley catheter can be used to hold the membranes in the uterus while the cerclage is placed; it is deflated and removed just before the knot is secured) [21], an
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Table 1 Retrospective studies addressing outcomes of RCC insertion. Study design
Number of RCC cases
Number of control patients
Outcome
Stupin et al. 2008 [7]
Retrospective case–control study
89
72 (conservative management, i.e. bed rest, tocolysis, and antibiotics)
Deb et al. 2012 [14]
Retrospective study
20
0
Yip et al. 1998 [15]
Retrospective study
19
0
Abo-Yaqoub et al. 2012 [16]
Retrospective study
43
0
Delabaere et al. 2011 [17]
Retrospective study
32
0
Ventolini et al. 2009 [24]
Retrospective case–control study
56
12 (expectant management)
Güdücü et al. 2013 [28]
Retrospective cohort study
25
0
Terkildsen et al. 2003 [29]
Retrospective with univariable and multivariable analysis
116
0
Debby et al. 2007 [30]
Retrospective cohort study
99 (24 with bulging of membranes and 75 without bulging of membranes)
0
Pereira et al. 2007 [31]
Historical cohort study
152
73 (expectant management)
Gupta et al. 2010 [32]
Retrospective cohort study
45 including 11 twin pregnancies
0
Fortner et al. 2012 [33]
110 (51 with cervical dilatation ≥2 cm and 59 with cervical dilatation b2 cm)
0
Celen et al. 2011 [34]
Retrospective cohort study with multivariate linear regression analysis Retrospective cohort study
75
0
Tezcan et al. 2012 [35]
Retrospective case–control study
Group 1: 19 (bulging membranes and symptoms [pain, pelvic pressure, vaginal discharge]) Group 2: 13 (bulging membranes without symptoms)
23 asymptomatic ultrasound-indicated cerclage
Significant increases in live birth rate (72% versus 25%), median birth weight (1340 g versus 750 g), and pregnancy duration (41 days versus 3 days) in the RCC group Presence of prolapsed membranes with infection causing rupture of membranes was the strongest predictor of poor outcome The duration of cerclage in situ was significantly longer if the procedure was performed at ≤20 weeks or if there were no prolapsed membranes at the time of presentation Significant increases in pregnancy duration at time of delivery and neonatal birth weight in women with RCC after 20 weeks Presence of infection, symptoms (abdominal pain, vaginal bleeding), bulging of membranes through the cervix, and cervical dilatation N3 cm were frequently associated with failure An observation period of 48 hours before the procedure did not significantly improve perinatal outcome if there was no uterine contraction and no maternal blood inflammation at admission Significantly longer median time from diagnosis to delivery in the RCC group (9.1 weeks vs 3.3 weeks) Patients with membranes prolapsing into the vagina had a lower success rate than those with membranes prolapsing to the external os (take-home infant rates of 31.3% and 68.8%, respectively) Nulliparity, membranes prolapsing beyond the external cervical os, and pregnancy duration b22 weeks at RCC were associated with a decreased chance of delivery ≥28 weeks Significantly higher mean pregnancy duration at delivery in the group without bulging of membranes (34.6 ± 4.6 vs 29.5 ± 3.2 weeks, respectively) RCC seems to prolong pregnancy and improve neonatal survival, compared with expectant management Prolapsed membranes, advanced cervical dilatation, maternal symptoms (abdominal discomfort, bleeding), and equivocal markers of infection were associated with a poor outcome Delivery at a shorter pregnancy duration if cervical dilation was ≥2 cm at the time of RCC insertion (27.0 weeks vs 35.6 weeks, P b 0.001) RCC can effectively prolong pregnancy to viability The rate of delivery at N34 weeks was 77.7%; the rate of premature delivery (28–34 weeks) was 12%; the rate of immature delivery (b28 weeks) was 8% RCC and ultrasound-indicated cerclage are best performed prior to symptoms In women with RCC, delivery b32 weeks was significantly more common in group 1 than in group 2 (79% versus 31%, P b 0.05)
Abbreviation: RCC, rescue cervical cerclage.
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Author and year of publication
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inflated balloon of the type used for endoscopic preperitoneal dissection [22], or a metreurynter or mini metreu (a rubber balloon device) inside the cervical os [23]. However, such techniques may be associated with an increased risk of iatrogenic PPROM. Alternatively, transabdominal amniocentesis and amnioreduction under ultrasound guidance can be performed to reduce the volume and pressure of the amniotic fluid in the prolapsed sac, thereby allowing the fetal membranes to retract back into the uterine cavity [12]. Emergency McDonald cerclage with the application of stay sutures made of 00 silk or polyglycolic acid has been strongly advocated as being technically easier to perform in an emergency situation with a dilated and effaced cervix, with the stay sutures allowing even traction on the whole cervical circumference, thus providing better conditions for the application of the purse-string suture than traction at 1 or 2 places by surgical instruments [20]. However, the choice between the Shirodkar and McDonald techniques should be made according to surgeon expertise and preference [24]. The application of transverse sutures from the anterior to the posterior parts of the cervix (Wurm technique), alone or in combination with a purse-string suture, has been described [19]. However, there is no current evidence to support the insertion of this cervical occlusion suture or the placement of a double purse-string suture as opposed to a single suture [2]. 3.2.3. Perioperative drugs (tocolytics, prophylactic antibiotics, and anesthesia) Data from uncontrolled retrospective studies [1,14,16,25] support the use of short-term tocolytics (especially indomethacin for its antiinflammatory and tocolytic effects) for 48 hours and the prophylactic administration of broad-spectrum antibiotics for a few days. However, these studies may be affected by biases, in particular selection bias, making it difficult to recommend or refute the value of these treatments. A single course of corticosteroids is recommended in women with a pregnancy duration of 24 weeks or more to enhance fetal lung maturation [26]. No studies are available comparing general with regional anesthesia for cerclage insertion and the decision should be individualized [2]. 3.3. Postoperative care Elective (history-indicated) cerclage is typically a day surgery, so women may be discharged after recovery from anesthesia once they are able to ambulate and void. However, after RCC placement it is good practice for the patient to remain in the hospital for a postoperative observation period of at least 24 hours, because of the increased risk of complications such as PPROM, early PTB, abortion, and infection [2]. On discharge, instructions are usually given to limit physical activity, avoid intercourse, and attend a prenatal clinic for assessment at 2-week intervals, despite the absence of comparative studies addressing these important issues [2,14]. Some authors [14] routinely prescribe supplemental progesterone as empiric medical therapy, but it is noteworthy that there is no evidence to confirm that this is helpful in women with prolapsed membranes. In addition, there are no studies assessing the usefulness of fetal fibronectin testing for the prediction of spontaneous PTB following RCC insertion, despite its high negative predictive value (more than 98%) in women with history- or ultrasound-indicated cerclage [27]. Notably, there are no studies comparing elective cerclage removal with removal during labor. In the absence of established PTB, elective removal at 36–37 weeks of pregnancy is preferable given the risk of cervical trauma should spontaneous labor occur with the suture in place, unless an elective cesarean delivery is to be performed with suture removal during the same setting [2]. In women with PPROM between 24–34 weeks of pregnancy and no infection or PTB, it is advisable to delay suture removal for 48 hours. This allows completion of a prophylactic course of steroids for fetal lung maturation and/or arrangement of an in-utero transfer. However, it is not recommended to delay suture
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removal until the onset of labor, to avoid the risk of maternal and fetal sepsis. Importantly, delayed suture removal is not beneficial in women with PPROM before 23 and after 34 weeks of pregnancy [2]. 3.4. Predictors of success The insertion of an RCC in women with advanced cervical dilatation with bulging membranes in the second trimester is essentially a salvage procedure. No informative RCT with a large sample size has been conducted to identify factors associated with the outcome of RCC. Many retrospective studies [7,14–17,24,28–35] have reported promising findings, with a trend toward improved outcomes with RCC (Table 1). To date, only 1 RCT [4] is available in this context; this trial evaluated the outcomes of RCC over a 5-year period. Twenty-three women who had prolapsed membranes at or beyond the external os before 27 weeks of pregnancy and without clinical signs of infection were randomized. Women in the study group (n = 13; 10 singleton pregnancies, 3 twin pregnancies) received an RCC, perioperative indomethacin, and bed rest until 30 weeks of pregnancy, whereas women in the control group (n = 10; 6 singleton pregnancies, 4 singleton pregnancies) received only bed rest until 30 weeks of pregnancy. A 1-week course of broad-spectrum antibiotics was prescribed for both groups. The 2 groups were demographically similar with a mean pregnancy duration of 22–23 weeks. The study [4] reported a 4-week difference in the pregnancy duration at delivery (mean 29.9 weeks; 95% confidence interval [CI], 24.8–34.9 versus 25.9 weeks; 95% CI, 23.0–29.2) in favor of the cerclage group, with the mean cerclage–delivery interval being 54 days versus 20 days (P = 0.04), and there was a significant reduction in the rate of PTB before 34 weeks of pregnancy (53% versus 100%; P = 0.02). A significant reduction in the rate of neonatal admission to the intensive care unit and/or neonatal death was reported in favor of the cerclage group (71% versus 100%; relative risk [RR], 1.6 [95% CI, 1.1–2.3]), and there was a trend toward an improvement in neonatal survival in the RCC group (56% versus 28%). There are some concerns about this study [4]. First, the study is underpowered (inclusion of only 23 patients, inclusion of twin gestations) to allow a firm conclusion. Second, the RCC group received indomethacin, which might have influenced the results. Third, no data were given on the degree of cervical dilatation and on the incidences of chorioamnionitis and neonatal morbidity. Another prospective nonrandomized study [36] conducted over a 6year period evaluated RCC for asymptomatic low-risk women (mean duration of pregnancy 22–23 weeks) with a dilated cervix (mean 4 cm) and bulging membranes. Women with a history of secondtrimester abortion or spontaneous PTB and those with clinical signs of infection were excluded. In total, 29 women underwent RCC and 17 women were managed expectantly. Pregnancy in the RCC group was prolonged by 8.8 weeks (range 0–17 weeks) compared with 3.1 weeks (range 0–11 weeks) among women who received bed rest alone, with a subsequent 3-fold reduction in PTB before 32 weeks of pregnancy (31% versus 94%; RR 0.33 [95% CI, 0.19–0.57]), a 2-fold increase in the live birth rate (86% versus 41%), and a 40% improvement in neonatal survival (96% versus 57%; RR 0.59 [95% CI, 0.0–0.76]) [36]. The results of this trial seem promising, but it was not randomized. Therefore, selection bias might have influenced the results. Additionally, the study included a small number of patients (n = 46). The use of RCC in twin and multiple pregnancies is a big source of debate. The available evidence from retrospective studies [37,38] indicates that it might be beneficial. One study [37] reported a success rate of 64.4% in terms of delivery beyond 28 weeks, whereas another study [38] reported an incidence of PTB before 34 weeks of 50% (95% CI, 23–77%) and a perinatal survival rate of 86% (95% CI, 67–96%). Properly designed RCTs comparing the outcomes of RCC with the outcomes of bed rest in twin pregnancies are needed to clarify this issue. Interestingly, 2 retrospective studies [25,39] have been carried out to develop a predictive model and a score to estimate the pregnancy
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3) ≥28 weeks of pregnancy (Model C)
Abbreviations: CRP, C-reactive protein; N, nulliparous; P, prior preterm delivery; F, prior full-term delivery; PTB, preterm birth; RCC, rescue cervical cerclage; WBC, white blood cell count. a The total score ranges from 0 to 15 points.
116 A retrospective analysis to develop a predictive model for pregnancy duration at delivery following RCC Grobman et al. 2008 [39]
2) 24–27 weeks of pregnancy (Model B)
0 2 Pregnancy duration at RCC ≤22.1 weeks of pregnancy: n = 74 N22.1 weeks of pregnancy: n = 42 ≤22.8 weeks of pregnancy: n = 95 N22.8 weeks of pregnancy: n = 21 ≤22.1 weeks of pregnancy: n = 74 N22.1 weeks of pregnancy: n = 42
0 4
0 1 2 4
0 4 5
85 A retrospective study with multivariate logistic regression analysis to develop a simple score for assessing the risk of early PTB (before 32 weeks of pregnancy) after RCC insertion
Variable 1) Obstetric history Multigravida without history of PTB Primigravida Multigravida with history of PTB 2) Cervical dilatation 1 cm 2 cm 3 cm ≥4 cm 3) Membranes Visible at external os Bulging into the vagina 4) Infection (WBC ≥13 600/mm3 or CRP N15 mg/L) No Yes Timing of delivery 1) b24 weeks of pregnancy (Model A)
Number of RCC cases Study design/aim
Fuchs et al. 2012 [25]
Author and year of publication
Table 2 Proposed scoring system and predictive model for assessing the risk of PTB in women undergoing RCC.
Main findings
Scorea
Parity N, P: n = 59 F: n = 57 N: n = 38 P, F: n = 78 N: n = 38 P, F: n = 78
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duration at delivery (Table 2), which might be used for prospective decision-making about the need for RCC. Grobman et al. [39] demonstrated that delivery before 24 weeks of pregnancy is best predicted by the presence of prolapsed membranes and the pregnancy duration at RCC insertion, whereas delivery between 24 and 27 weeks of pregnancy is best predicted by parity alone (Table 2). Delivery at a pregnancy duration of 28 weeks or more was best predicted by cervical dilation and length, the presence of prolapsed membranes, and parity. Overall, it was concluded that the last model (cervical dilation and length, presence of prolapsed membranes, and parity) presented the most accurate results to predict delivery at the 3 different pregnancy durations [39]. Fuchs et al. [25] analyzed the outcome of RCC in 85 women with a singleton pregnancy who presented with a spontaneously dilated cervix (dilation 1 cm or more) on physical examination and visible membranes at the external cervical os (n = 37) or with bulging of the membranes into the vagina (n = 48) during speculum examination, and who had no contractions. Multiple logistic regression analysis showed that 4 variables—obstetric history, bulging of membranes into the vagina, cervical dilatation, and infection—independently predicted the risk of early PTB (before 32 weeks) (Table 2). A score ranging from 0 to 15 points was proposed, and total score values of 0, 5, 10, and 15 were associated with early PTB probabilities of 8.6%, 39%, 81.2%, and 97%, respectively [25]. The same authors [40] reported that ultrasound measurement of the cervical length is not better at predicting early PTB (before 32 weeks) than clinical assessment of cervical dilation in women with an RCC. 4. Conclusion A common belief is that RCC may be the only hope to rescue a pregnancy in patients with advanced cervical changes and prolapsed membranes in the second trimester. However, RCC is a surgical procedure with well-defined operative risks. Current evidence from numerous retrospective and a few prospective nonrandomized studies has shown a benefit of RCC. It may prolong pregnancy by an average of 4–5 weeks with a 2-fold reduction in the chance of PTB before 34 weeks of pregnancy. However, data supporting an associated improvement in neonatal mortality or morbidity are limited. Notably, a higher chance of cerclage failure is expected if cervical dilatation exceeds 4 cm or if the fetal membranes are bulging into the vagina. Therefore, the decision to insert an RCC should be individualized and undertaken after comprehensive patient counseling and a review of the specific circumstances, with full involvement of a senior obstetrician. Further research in the form of robust RCTs is recommended to clarify the fundamental concerns in this complex subject area. Conflict of interest The authors have no conflicts of interest. References [1] Nelson L, Dola T, Tran T, Carter M, Luu H, Dola C. Pregnancy outcomes following placement of elective, urgent and emergent cerclage. J Matern Fetal Neonatal Med 2009;22(3):269–73. [2] Royal College of Obstetricians and Gynaecologists. Cervical Cerclage: Green-top Guideline No. 60. http://www.rcog.org.uk/files/rcog-corp/GTG60cervicalcerclage. pdf . Published May 2011. [3] Liddiard A, Bhattacharya S, Crichton L. Elective and emergency cervical cerclage and immediate pregnancy outcomes: a retrospective observational study. JRSM Short Rep 2011;2(11):91. [4] Althuisius SM, Dekker GA, Hummel P, van Geijn HP. Cervical incompetence prevention randomized cerclage trial. Cervical incompetence prevention randomized cerclage trial: emergency cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol 2003;189(4):907–10. [5] Olatunbosun OA, al-Nuaim L, Turnell RW. Emergency cerclage compared with bed rest for advanced cervical dilatation in pregnancy. Int Surg 1995;80(2):170–4.
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